# K040044: Heel Snuggler, Model 99047

- Pathway: 510(k) (Traditional)
- Applicant: Respironics, Inc.
- Decided: Jan 27, 2004 after 15 days
- Product code: MPO (Infant Heel Warmer (Chemical Heat Pack))
- Device class: 1
- Regulation: 21 CFR 890.5710
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K954716 (1996). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K954716: Deroyal Industries Infant Heel Warmer, Debusk Knitting Mills, Div. Deroyal Industries (1996) Summary page 2.

## Recalls of this device
- Nov 29, 2021 · Class II · Z-0507-2022: After the device was cleared by the FDA, Philips made changes to the labeling that do not fall within the existing FDA clearance. These devices with the modified labeling cannot be distributed or sold

## Indications for use
The Respironics Heel Snuggler infant heel warmer is intended for use whenever circulation needs to be stimulated in the infant heel in order for blood sampling to occur.

Source page: https://510kreport.com/device/K040044
Methodology: https://510kreport.com/methodology